Research outcomes and recommendations for the assessment of progression in cancer clinical trials from a PhRMA working group

Author:

Stone A.M.,Bushnell W.,Denne J.,Sargent D.J.,Amit O.,Chen C.,Bailey-Iacona R.,Helterbrand J.,Williams G.

Publisher

Elsevier BV

Subject

Cancer Research,Oncology

Reference32 articles.

1. FDA Oncologic Drugs Advisory Committee: endpoints for colorectal cancer regulatory approval. http://www.fda.gov/ohrms/dockets/ac/04/transcripts/4037T2.DOC; 4th May, 2004.

2. FDA guidance for industry clinical trial endpoints for the approval of cancer drugs and biologics. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071590.pdf; May 2007.

3. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1);Eisenhauer;Eur J Cancer,2009

4. Commentary concerning demonstration of safety and efficacy of investigational anticancer agents in clinical trials;O’Shaugnessy;J Clin Oncol,1991

5. End points and United States Food and Drug Administration approval of oncology drugs;Johnson;J Clin Oncol,2003

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